Sterile Vascular Access Enclosure for Single-User CVC Placement
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Solution Overview
Problem
Current methods for sterile vascular access, such as placing central venous catheters, are time-consuming and prone to interruptions, requiring repeated preparations and increasing the risk of infections, especially in intensive care settings where a single user cannot easily manage the process without compromising sterility.
Innovation Solution
A flexible, transparent, pathogen-impermeable medical-grade enclosure with an adhesive base and tubular top portion that creates a sterile environment, allowing single-user preparation and application, with features like finger cavities and an inflatable design to maintain sterility and facilitate access, reducing the need for repeated preparations and minimizing infection risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sterile vascular access procedures are performed with multiple users and repeated preparations, then sterility can be maintained through multiple hands, but the procedure becomes time-consuming and prone to interruptions
Solution Approach 1:
The sterile enclosure is pre-assembled with all necessary components (catheter, syringe, needle, guidewire) arranged in a predetermined sequence before sterilization. This preliminary preparation eliminates the need for time-consuming setup during the procedure while maintaining sterility through the sealed enclosure design.
Solution Approach 2:
Multiple components are nested within the sterile enclosure in a compact arrangement - the catheter is positioned within the enclosure, the syringe contains the needle, and the guidewire is stored within the catheter. This nesting allows all components to be contained within a single sterile unit, enabling one-user operation without compromising sterility.
2Productivity
If a single user performs the procedure without interruption, then operational flexibility is improved, but maintaining sterility becomes more challenging
Solution Approach 1:
The procedure is segmented into distinct phases, each requiring only specific components that are pre-positioned within the sterile enclosure. The enclosure itself is segmented into compartments that separate sterile from non-sterile areas, allowing a single user to perform the entire procedure without breaking sterility by providing organized access to each component in sequence.
Solution Approach 2:
The sterile enclosure acts as an intermediary barrier between the sterile medical components and the non-sterile external environment. This single-use sealed enclosure mediates the interaction between the user's hands and the sterile components, allowing manipulation of sterile items without direct contact that would compromise sterility.
3Loss of time
If all vascular access components are included in a single sterile enclosure, then preparation time is reduced, but the device complexity increases
Solution Approach 1:
The sterile enclosure utilizes a flexible, transparent plastic film or bag that can be easily sealed and manipulated. This flexible shell design allows the enclosure to conform to the nested components while maintaining sterility, and the transparency enables visual verification of component presence and integrity without compromising the sterile barrier.
Data Source
AI summary
A sterile vascular access device for placing a central venous catheter (CVC) on a human subject, said device comprising: a flexible enclosure formed of a flexible, transparent, pathogen impermeable medical grade material, said flexible enclosure having a base portion and a top portion, said base portion and said top portion together defining an internal space of the flexible enclosure, said base portion having an adhesive bottom surface adapted to be reversibly attached to the skin of the subject and a top surface connected to the top portion, and said top portion comprising a tubular portion having a proximal end which is connected to the top surface of the base portion and a distal end which is sealed.